Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients

NCT03413696 | Completed

• 2 other identifiers: 20170991170218
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

A clinical observational study for patients with HIV co-infected with hepatitis C that investigates the levels of their health literacy, hepatitis C and HIV knowledge. Participants will complete a one-time assessment of these studied domains and categorized in three groups defined by their hepatitis C treatment referral status: not-referred, referred-attended, referred and no-show.

Conditions

Hepatitis C; Hepatitis C, Chronic; HIV/AIDS

Keywords

HIV; Health literacy; Hepatitis C; Hepatitis C knowledge; HIV knowledge; Hepatitis C treatment

Outcome Measures

Primary Outcomes (1)

• Inadequate health literacy (s-TOFHLA inventory)

  The primary outcome will measure the point prevalence of inadequate health literacy among persons with HIV/AIDS with active hepatitis C infection.

  Baseline before HCV treatment consideration

Secondary Outcomes (1)

• Hepatitis C knowledge (using the modified Treolar's scale)

  Baseline before HCV treatment consideration

Other Outcomes (2)

• Determinants of inadequate health literacy and HCV knowledge

  Baseline before HCV treatment consideration

• Predictors of patient willingness to HCV treatment

  Baseline before HCV treatment consideration

Study Arms (3)

Not referred for HCV therapy

Referred for HCV therapy,did not show up

Referred,attended HCV therapy evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients living with HIV, coinfected with HCV, who are receiving care at the UCSD Owen Clinic at the time of data collection

You may qualify if:

• Any adult (≥ 18 years) HIV-infected patient attending the UCSD Owen Clinic
• Regardless of ethnic background
• English or Spanish speaking
• With active HCV infection defined as having a detectable HCV viral load with or without a positive HCV antibody

You may not qualify if:

• Neurocognitive impairment precluding participation
• Physical illness precluding participation

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

Owen Clinic - University of California, San Diego

San Diego, California, 92103-8186, United States

Location

MeSH Terms

Conditions

Hepatitis C; Hepatitis C, Chronic; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Hepatitis, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; HIV Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Edward Cachay, MD, MAS

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Medicine

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: January 29, 2018
• Study Start: September 8, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: September 5, 2021

Record last verified: 2021-09

Locations

US (1)